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Institutional Review Board (IRB): Consent Letters

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When do I need a consent letter?

You are required to write a consent letter for your NCU IRB application if all of the following are true:

  1. You plan to conduct human subjects research
  2. You will be recruiting participants who are age 18+

Introduction to Consent

You will write a consent letter so that potential participants have all the information about your study in one place and can make an informed decision as to whether they want to participate in your study. A consent letter is just one part of the informed consent process. Informed consent is an ongoing process that begins during recruitment and continues throughout the study.

How do I collect consent?

If you are engaging with participants in real-time (interviews, focus groups, observations, etc.), you may send potential participants a copy of the consent letter before you meet with them. You then must do the following:

  1. Set aside time to read through the consent letter with each participant. As you read through, remind participants that they do not have to participate if they do not want to, they can skip any question they do not want to answer, they can skip any activity they do not want to participate in, and they can stop participating at any time.
  2. Give participants an opportunity to ask questions about your study.
  3. Ask participants for verbal consent (e.g., "Do you still want to participate in this study?"). For Exempt and Expedited studies, the NCU IRB does not require you to collect participant signatures or any written documentation of consent (if you are using a site IRB, they may require participant signatures). For more information, watch the webinar below:

If you are distributing an Online Survey or Questionnaire, you will do the following:

  • Place your consent letter on the first page of your survey
  • Have a question that asks participants if they agree or disagree to be in your study
  • Do not allow participants who disagree to view or answer the survey questions

When do I collect consent?

After you have received IRB approval. You should not consent participants or collect data until you have IRB approval.

Writing a Consent Letter

You are required to use the NCU IRB consent letter template below, unless you are working with an IRB/ HRPP that is requiring you to use their template.

You will also be required to provide a Readability Report for your consent letter.

Do I need to reword the template to avoid plagiarism?

No! Using a required template is not plagiarism. The consent letter template has language that is required by federal regulations. You should not change or revise any of the template language.

How do I write my consent letter if I have multiple participant groups?

If you have multiple participant groups who are all doing the same activities and answering questions about the same topics, you will use 1 consent letter for all groups. You should add subheadings to the eligibility section to clearly label each group and list the criteria separately for each group. Review the Consent Letter Examples for assistance.

If any of your participant groups are doing different activities or answering questions about different topics, you will use a separate consent letter for each group.

Get feedback on your consent letter

The NCU IRB recommends that you receive feedback on your consent letter before you submit your IRB application:

Submitting Your Consent Letter

You will upload your consent letter in the "Consent Procedure & Materials" section of your IRB application.

The documents you upload to your IRB application should be ready to send to the participants. Double-check the following:

  • Don't change or reword any of the required template language
  • Remove all blue highlighting, template instructions, and optional sections that aren't applicable to your study
  • Remove any Track Changes or comments from your chair or the IRB
  • Do not include any labeling or formatting from your dissertation (Appendix, etc.)

Consent Template & Resources

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